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Can a simple home breathing device keep COPD patients out of the hospital?

NCT ID NCT06970054

Disease control Sponsor: Sir Run Run Shaw Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a handheld breathing device (OPEP) at home, combined with aerobic exercise, can reduce serious flare-ups and hospital visits in people with moderate to severe COPD. About 312 participants aged 40-80 will be split into four groups: standard care, OPEP alone, exercise alone, or both together. They will use wearable monitors and follow training plans for 8 weeks, with follow-ups over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oscillatory Positive Expiratory Pressure (OPEP) device and aerobic exercise
What this could lead to
If successful, this could offer a practical home-based program to reduce COPD flare-ups and hospital stays, improving daily life for people with moderate to severe COPD.
What could go wrong
This is a mid-stage study with 312 participants, so results may not apply to everyone. The interventions require daily effort, and long-term benefits or risks are not yet fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 312 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 40-80 years. * Diagnosis of AECOPD according to 2025 GOLD criteria, GOLD stage 2-4. * Patients seeking treatment for acute exacerbation of COPD (AECOPD) as outpatients or inpatients. * Residing in the study center area with no plans to relocate during the study. * Voluntary participation with signed informed consent. Exclusion Criteria: * Inability to walk or tolerate the 6-minute walk test. * Inability to cooperate with lung function tests. * Life expectancy \<6 months (e.g., uncontrolled advanced malignancy, recent MI, unstable angina, acute stroke, acute heart failure). * Active pulmonary tuberculosis or history of lung resection. * Pregnancy or lactation. * Liver or kidney failure requiring dialysis. * Participation in other drug clinical trials or interventional studies. * Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill, illiterate). * Other reasons deemed unsuitable by the researcher.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AECOPD COPD

Contacts and locations

Locations

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.